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| Product NDC Code | 67226-2050 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 106309 | ||||
| Application Number | M006 | ||||
| Labeler Name | Vivier Pharma, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzoyl Peroxide 5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Wash hands with a non-medicated soap (contains no Benzoyl Peroxide). Cleanse and dry face thoroughly 5 minutes before use. Using fingertips apply evenly to affected areas. Use both morning and night or as directed by a physician. If dryness or peeling occurs, reduce application to once a day or every other day. Fair- skinned individuals should begin with one application. For more severe cases, and/or if substantial improvement is not apparent within 3 to 4 weeks, consult a health care practitioner.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients C13-14 Isoparaffin, Ethylhexylglycerin, Lanolin Oil, Laureth-4, Laureth-7, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Water/Eau, Xanthan Gum.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.
Purpose
Information about the drug product’s indications for use.Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.Acne Treatment BENZOYL PEROXIDE C13-14 ISOPARAFFIN ETHYLHEXYLGLYCERIN LANOLIN OIL LAURETH-4 LAURETH-7 MAGNESIUM ALUMINUM SILICATE PHENOXYETHANOL PROPYLENE GLYCOL WATER XANTHAN GUM BENZOYL PEROXIDE BENZOYL PEROXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5% 1 2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you are using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have very sensitive skin. are sensitive to Benzoyl Peroxide.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation becomes severe.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid unnecessary sun exposure and use a sunscreen avoid contact with eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower oncentration.
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at room temperature (59-86°F / 15-30°C)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API